Miami Cardiac & Vascular Institute First in Florida to Use New ‘Puncture and Access’ System for Structural Heart Procedures

Miami Cardiac & Vascular Institute, part of Baptist Health, is the first medical center in Florida to use an innovative new system to create a small surgical passage through the atrial septum — the wall between the right and left atrium of the heart. This innovation is designed to provide safer and more predictable outcomes during vital structural heart procedures that require this so-called “transseptal puncture and access” into the heart.

Ramon Quesada, M.D., medical director of the Structural Heart and Complex Percutaneous Coronary Intervention programs at Miami Cardiac & Vascular Institute, successfully used the system for a left atrium appendage closure (LAAC) case.

Ramon Quesada, M.D., medical director of the Structural Heart and Complex Percutaneous Coronary Intervention programs at Miami Cardiac & Vascular Institute.

The all-in-one system is fully known as the SafeCross^™ Transseptal Radiofrequency Puncture and Steerable Balloon Introducer System, or SafeCross. It consists of a bi-directional steerable introducer sheath to reduce the risk of atrial wall perforation. SafeCross also provides a radiofrequency puncture dilator, making it a needle-less system. SafeCross is from East End Medical, a private medical device company based in South Florida.

“This system is exactly what we were looking for in a new transseptal crossing device,” said Dr. Quesada. “The highly-visible positioning balloon of the SafeCross allowed me to quickly target the precise location of the heart I wanted to access. The radiofrequency puncture built into the system made the puncture process very smooth and safe. I look forward to using this system in more of my procedures.”

The left atrial appendage (LAA) is a small pouch on your heart’s left atrium, where blood normally flows in and out. In patients with AFib (atrial fibrillation), an irregular heartbeat that is caused by irregular electrical signals in your heart, blood clots can form in the LAA.  Procedures that can utilize the SafeCross system will reduce the risk for future strokes, much like take blood thinners would. Patients may not need to take blood thinners after undergoing a left atrial appendage closure.

In recent years, Miami Cardiac & Vascular Institute has taken a leading role in clinical studies that have led to approvals by the U.S. Food and Drug Administration. The most recent case involved the Amplatzer Amulet, from Abbot Medical, which received FDA approval in August 2021. Last fall, a team at the Institute led by Dr. Quesada became the first in Florida to implant the device in patients — a man in his 70s and a woman in her 80s. Both are doing well.

The Amulet device effectively closes off the heart’s left atrial appendage (LAA) to keep harmful blood clots from entering the blood stream and potentially causing a stroke. In a randomized clinical trial in which the Institute and a team led by Dr. Quesada played a key role, the Amulet provided a better “sealing” of the LAA, compared to the older technology known as WATCHMAN (a superior and updated version of this device, WATCHMAN FLX from Boston Scientific, is being used by the Institute in addition to the Amulet).